A Study to Assess the Efficacy of Intravenous Bondronat (Ibandronate) in Patients With Malignant and Painful Bone Disease

Roche

Status and phase

Terminated

Phase 3

Conditions

Bone Neoplasm

Neoplasm Metastasis

Pain

Treatments

Drug: zoledronic acid

Drug: ibandronate [Bondronat]

Study type

Interventional

Funder types

Industry

Identifiers

NCT00099203

BO18040

Details and patient eligibility

About

This 2 arm study will compare the efficacy of intravenous Bondronat with that of zoledronic acid in patients with malignant bone disease experiencing moderate to severe pain. Patients will be randomized to receive either Bondronat (6mg iv on days 1, 2 and 3 and then every 3-4 weeks) or zoledronic acid (4mg iv on day 1 and then every 3-4 weeks). The anticipated time of study treatment is 6-12 months, and the target sample size is 100-500 individuals.

Enrollment

163 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

patients with malignant bone disease;
patients with moderate to severe pain.

Exclusion criteria

patients who have received a bisphosphonate within 3 weeks from the signing of the informed consent;
patients receiving concurrent investigational therapy, or who have received investigational therapy within 30 days of the first scheduled day of dosing;
untreated esophagitis or gastric ulcers;
recent or pre-scheduled radiotherapy to bone;
patients who are pregnant or breast-feeding.